Attorney General Eric Holder issued the following statement today in response to a federal jury in Manhattan’s unanimously reaching a guilty verdict against Abu Hamza al-Masri.

The Department of Justice will require ConAgra Foods Inc., Cargill Inc., CHS Inc. and Horizon Milling LLC to divest four competitively significant flour mills in order to proceed with the formation of Ardent Mills, a flour milling joint venture.

Sixteen current and former Puerto Rico police officers have been indicted for their alleged participation in a criminal organization, run out of the police department, that used their affiliation with law enforcement to make money through robbery, extortion, manipulating court records and selling illegal narcotics.

The Justice Department today announced a multi-national effort to disrupt the Gameover Zeus Botnet – a global network of infected victim computers used by cyber criminals to steal millions of dollars from businesses and consumers – and unsealed criminal charges in Pittsburgh, Pennsylvania, and Omaha, Nebraska, against an administrator of the botnet.

Evgeniy Bogachev and the members of his criminal network devised and implemented the kind of cyber crimes that you might not believe if you saw them in a science fiction movie. By secretly implanting viruses on computers around the world, they built a network of infected machines – or “bots” – that they could infiltrate, spy on, and even control, from anywhere they wished.

Today, we are here to announce that, over the weekend, the Department disrupted two extremely damaging cyber threats – the financial botnet known as Gameover Zeus and the malicious software known as Cryptolocker.

Attorney General Eric Holder released the following statement Tuesday regarding the arrest of Ahmed Abu Khatallah for his role in the attack on the U.S. facilities in Benghazi, Libya

Ahmed Abu Khatallah, aka Ahmed Mukatalah, a Libyan national approximately 43 years of age, has been charged for his alleged participation in the Sept. 11, 2012, attack on the U.S. Special Mission and Annex in Benghazi, Libya, which resulted in the deaths of four Americans

JC Stamps, a former union official, pleaded guilty today to embezzling more than $190,000 from two labor organizations he founded and an employee benefit plan

Attorney General Eric Holder announced today that the Obama administration, as part of successfully concluding negotiations on the E.U.-U.S. Data Protection and Privacy Agreement (DPPA), would seek to work with Congress to enact legislation that would provide E.U. citizens with the right to seek redress in U.S. courts if personal data shared with U.S. authorities by their home countries for law enforcement purposes under the proposed agreement is subsequently intentionally or willfully disclosed, to the same extent that U.S. citizens could seek judicial redress in U.S. courts for such disclosures of their own law enforcement information under the Privacy Act

On the one-year anniversary of the Supreme Court decision that struck down a key part of the Voting Rights Act, Attorney General Eric Holder pledged Wednesday that the Justice Department would remain aggressive in using Section 2 of the law—which was left intact by the Court’s decision—to guard against unjust voting restrictions

Ahmed Abu Khatallah, aka Ahmed Mukatallah, made his first appearance today in the U.S. District Court for the District of Columbia on a federal terrorism offense arising from his alleged participation in the Sept. 11 through 12, 2012, terrorist attacks in Benghazi, Libya, which resulted in the deaths of Ambassador J. Christopher Stevens, Sean Smith, Tyrone Woods and Glen Doherty

A member and an associate of the Lucchese organized crime family and two Texas brothers were convicted today of racketeering and other charges after a six-month trial

George Washington himself conceived and designed them, but it was Mount Vernon’s other residents -- the hundreds of men and women who worked for Washington -- it was their hands that built and tended this splendor. Like you, those men and women had origins that stretched around the globe. They were Christians and Muslims; Africans and Europeans.

The Justice Department today filed a status report with the United States District Court for the Western District of Pennsylvania updating the court on the progress in disrupting the Gameover Zeus botnet and the malicious software known as Cryptolocker

Two West Bloomfield, Michigan, residents pleaded guilty in the U.S. District Court for the Eastern District of Michigan today, announced the Justice Department and Internal Revenue Service (IRS).

I am honored to join you in this pursuit. I congratulate you, once again, on this extraordinary occasion. And I thank you for allowing me to share it with you.

Three defendants were arrested today on charges of providing material support to al-Shabaab, a designated foreign terrorist organization that is conducting a violent insurgency campaign in Somalia

The former president and chief executive officer of BizJet International Sales and Support Inc., a U.S.-based subsidiary of Lufthansa Technik AG with headquarters in Tulsa, Oklahoma, that provides aircraft maintenance, repair and overhaul services, pleaded guilty today for his participation in a scheme to pay bribes to foreign government officials

Frederic Cilins, a 51-year old French citizen, was sentenced today in the Southern District of New York to 24 months in prison for obstructing a federal criminal investigation into alleged bribes to obtain mining concessions in the Republic of Guinea

A federal jury in Omaha, Nebraska, found Donna Marie Kozak guilty on Friday of conspiracy to file and filing false liens against two U.S. District Court judges, the U.S. Attorney for the District of Nebraska, two Assistant U.S. Attorneys and an Internal Revenue Service (IRS) special agent, the Justice Department announced

A Beverly Hills, California man was sentenced today in the U.S. District Court for the Central District of California to serve six months in prison and one year of home confinement for filing a false federal income tax return for tax year 2007, the Justice Department and Internal Revenue Service (IRS) announced

The Justice Department reached an agreement today with Travel Management Company, a private airplane charter company based in Elkhart, Indiana, resolving claims that the company engaged in citizenship status discrimination in violation of the Immigration and Nationality Act (INA).

Fourteen individuals were charged in three indictments in Puerto Rico with conspiracy to commit identification fraud, money laundering, aggravated identity theft and passport fraud in connection with their alleged roles in a scheme to traffic the identities and corresponding identity documents of Puerto Rican U.S. citizens

Waldemar Lorenzana Sr., 75, the patriarch of the Lorenzana drug trafficking organization in Guatemala, pleaded guilty today to conspiracy to import over 450 kilograms of cocaine into the United States

Sixteen former Puerto Rico police officers have pleaded guilty for their roles in a criminal organization run out of the police department. The officers used their affiliation with law enforcement to commit robbery and extortion, to manipulate court records in exchange for bribes, and to sell illegal narcotics

The former Hanover Corporation chief financial officer and a former Hanover salesman were sentenced today to serve 60 months in prison and 70 months in prison respectively, and ordered to pay $14,454,999.19 in restitution, for their roles in an $18 million Ponzi scheme. Hanover’s former chief executive officer was previously sentenced to 14 years in prison and ordered to pay $14,784,983.75 in restitution in this case

A U.S. citizen living in Amsterdam, Netherlands, was sentenced today to serve 35 years in prison for sexually exploiting a minor in California and elsewhere and producing images of that abuse.

Today, the Justice Department asked a federal court to dismiss the injunction to address civil rights violations at Saint Elizabeths Hospital in Washington, D.C., because the District of Columbia and the Department of Behavioral Health have significantly improved the care and treatment of persons confined to Saint Elizabeths Hospital. Saint Elizabeths is the district’s facility for treating individuals with mental health conditions. The reforms, which were implemented following requirements under a court order, have ensured that persons at Saint Elizabeths Hospital are discharged to the community with adequate supports to live in integrated settings. Further, the reforms resulted in important improvements in integrated treatment planning, psychological and psychiatric services, nursing care and protection from assault.

The Justice Department announced today the filing of a lawsuit with the Executive Office for Immigration Review against Louisiana Crane Company LLC (Louisiana Crane), which is headquartered in Eunice, Louisiana.

Costco Wholesale Corporation, one of the nation’s largest retailers, has agreed to cut its emissions of ozone-depleting and greenhouse gases from leaking refrigeration equipment at more than half of its stores nationwide.

The Department of Justice has seized approximately $500,000 in assets traceable to corruption proceeds accumulated by Chun Doo Hwan, the former president of the Republic of Korea. This seizure brings the total value of seized corruption proceeds of President Chun to more than $1.2 million.

A federal jury in Omaha, Nebraska, found a Pelham, Georgia, man guilty late yesterday of seven counts of conspiracy to file and filing false liens against two U.S. District Court judges, the U.S. Attorney for the District of Nebraska, two Assistant U.S. Attorneys and an Internal Revenue Service special agent.

Shannon Conley, age 19, of Arvada, Colorado, pleaded guilty this morning before U.S. District Court Judge Raymond P. Moore to one count of conspiracy to provide material support to a designated foreign terrorist organization, U.S. Attorney John Walsh for the District of Colorado and Special Agent in Charge Thomas Ravenelle of the FBI Denver Division announced. Conley is scheduled to be sentenced by Judge Moore on January 23, 2015. The defendant appeared at the change of plea hearing in custody, and was remanded at its conclusion.

A former LaPorte County deputy auditor has been indicted by a federal grand jury in the Northern District of Indiana for embezzling over $150,000 from the LaPorte County government and committing tax fraud.

Benjamin Pierce Bishop, 60, a former Honolulu, Hawaii, civilian defense contractor and retired lieutenant colonel in the U.S. Army, was sentenced today by U.S. District Judge Leslie E. Kobayashi to serve 87 months imprisonment and three years’ supervised release for willfully communicating classified national defense information to a person not authorized to receive it and unlawfully retaining classified national defense information at his home.

Today's Daily Dose brings you news about Cassava Sciences' research grant from the National Institutes of Health for developing Alzheimer's disease drug; Edwards Lifesciences' Q1 financial results; Enzo Biochem's launch of the next-generation COVID-19 test kits and Johnson & Johnson's deal with Emergent BioSolutions related to COVID-19 Vaccine candidate.

Older adults who consumed large amounts of flavonoid-rich foods were two to four times less likely to develop Alzheimer's disease and related dementias over 20 years compared with people whose intake was low, in a study of 2,800 people.

Equal pay, migrant workers, and maternal health are the issues highlighted by the finalists of the inaugural APEC Healthy Women, Healthy Economies Research Prize.

A comprehensive study on the health needs of Filipino migrant workers has won the inaugural APEC Healthy Women Healthy Economies award.

An APEC Business Travel Card mobile application will make travel easier and more secure

The impact of corruption is far-reaching and devastating, especially for women.

Research Promoting Women’s Health to Receive $20,000 Prize

The first Senior Officials Meeting for APEC Malaysia 2020 begins

From : Communities>>Regulatory Open Forum
I disagree with Richard. I just had a conversation with the COVID-19 hotline (11:45 am, May 7) and asked about this issue after having read an update from the FDA that said UDIs for EUA devices are waived and GMPs are under limited enforcement. The person I spoke with said the update is correct and that UDIs are waived for EUA devices.  Feel free to contact me if you have any questions.  Bob Bard ------------------------------ Robert Bard JD, RAC [Managing Director] South Lyon MI United States - [More]

From : Communities>>Regulatory Open Forum
Bob, I stand corrected; if you confirmed with FDA that is good.  From what I was reading and seeing (I must have missed that update) there was nothing addressing UDI or no UDI.for EUA products.  (Personally I am a bit surprised at this since the whole concept of UDI is traceability and they waive this for emergency use products - when there is an issue this is where UDI becomes so important.  Shrugs.) ------------------------------ Richard Vincins RAC Vice President Global Regulatory Affairs --- [More]

From : Communities>>Regulatory Open Forum
Hello Richard, Yesterday, I received a follow up from the Hotline (CDRH-EUA-Templates ) to my query. I was reminded that the waiver to good manufacturing practice and labeling requirements were included in the individual authorization letter. The person responding to my question concerning the UDI requirement provided the following: UDI is not specifically noted; however we are not enforcing UDI during the emergency. The specific authorization letter I was reviewing was for [More]

From : Communities>>Regulatory Open Forum
Hi, Willard - The Product code RHP won't show any 510(k)s because that is not a match for any regulated medical device. You can see the classification in the "Radiation Emitting Electronic Product Codes" page (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm?PCD=RHP), where it also notes that for this Product Code, there are no applicable standards for these "UV Lamp, Germicidal" products.  If it were a medical device, it might fall under FDA's classification for certain [More]

From : Communities>>Regulatory Open Forum
Good morning, Willard. In the U.S., disinfectants fall under the jurisdiction of both the FDA and EPA.  The agencies have an MOU in place to better define there roles.  Accordingly, devices that are  intended for "trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than bacteria, virus, or other microorganism on or in living man or other living animals). . ." are defined as "pesticide devices", under  FIFRA section 2(h),.    Pesticide [More]

What can small sponsors do to secure the outsourcing resources they need as large CROs form strategic alliances with Big Pharma?

Partenships between large pharmaceutical companies and large CROs have become the norm.  The advantages for sponsor companies include shared risk, knowledge transfer, dedicated resources, shorter time to market, and the ability to implement the massive data integration that clinical development requires.  Strategic alliances are arguably as advantageous for their outsourcing partners, providing a steady pipeline of work that’s larger in scope and longer in duration than is typical under traditional arrangements.



Strategic Partnerships in Big Pharma: Implications for the Rest
Advantages for one segment of the industry can introduce disadvantages for another.  Alliances among the large players increase competition for top-drawer CRO resources. Smaller sponsors may find it more difficult to receive the quality of service and level of commitment they might otherwise expect.  A large CRO is likely to assign their most talented personnel to projects associated with their strategic partners.  And if a partner study were to run into trouble, it would be hard to fault a CRO for pulling experienced staff members off a smaller project in order to help out with the big client.  Though a reputable CRO wouldn’t jeopardize the relationship with the smaller client, their responsiveness to routine requests might suffer.  It might take longer to get a question answered, receive requested documentation, making the job of vendor oversight difficult.

Though selecting a large, well-established CRO at the outset may have seemed like the safe bet, what do you do if you’re a small sponsor or biotech start-up who is dissatisfied with the level of service you’re receiving?

“Let’s Bring It In-house.”
Put off by a negative experience, many companies decide to curtail outsourcing, and bring functions like monitoring and project management in-house.

This response is understandable, but it rarely goes well.  There’s good reason to outsource study functions to a CRO, especially if you’re small, or new, or both.  Mid-study is a terrible time to realize you’re in over your head.  You may find it difficult to contract with the service providers you want in the timeframe you need them.  Services you would have preferred be performed by a single company may now have to be farmed out piecemeal, which has the overhead of multiple contracts and makes vendor oversight more difficult to manage.  You don’t have time to go through a thorough qualification process.  You’re not in a good bargaining position; you’re trying to buy a new car after they’ve towed away your old one.  And now you have to rely on your new service provider(s) – the ones who may not be your first choice, whom you had to choose in haste, whom you didn’t get to thoroughly vet – to jump in midstream and pick up a study that is already in trouble.

Options for Small Sponsors and Start-ups
So what’s the answer?  You have several good options we’ve seen work well for smaller organizations.

(1) Go smaller.  Look beyond traditional outsourcing choices and consider selecting smaller vendors who may well be in a better position to focus on individual projects and give priority to shorter term engagements.  After all, a project that’s small to a big CRO will be comparatively big to a small CRO.

(2) Go long-term.  Consider establishing strategic partnerships of your own.   Doing so would increase the expertise and technology to which you’d have ready access, and could extend your global reach.

(3) Go big, but go vigilantly.  There’s a reason companies hire big, reputable CROs.  ‘Big’ means the CRO has an impressive set of resources at its disposal.  ‘Reputable’ means it has a proven record of successfully completing studies, producing reliable data, and preserving subject safety.  Smaller sponsors can still take advantage of everything a big CRO offers if they can commit to conducting very strict vendor oversight.  They need to closely monitor the quality of the work the CRO performs, frequently assess adherence to the many written study plans, and make sure deadlines are being met.  Service contracts should guarantee a certain level of responsiveness (by specifying maximum turn-around times, for example), especially for those requests that enable these oversight activities.


Qualification is Key
While the key to Option 3 is effective vendor management, the key to Options 1 and 2 is effective vendor qualification.  Resources are tight in a small company, so you need to direct them where your exposure is greatest, where they’ll do the most good.  What could be more essential to the success of your study than choosing the right company to conduct it?   Many sponsors conduct on-site vendor audits.  That’s good.  That’s necessary.  But it’s not sufficient.  To consistently choose the best possible CRO for your study, sponsors need to:

• Formally document and maintain vendor selection criteria and qualification process
• Form selection committees that represent all sides of your business – finance, contracting, operations, finance, QA, data management, pharmacovigilance, biostatistics, etc.
• Conduct on-site audits with well-trained, well-prepared QA auditors
• Track the resulting CAPA activities
• Ensure outstanding issues are resolved before the contract is signed
• Periodically re-evaluate vendors to make sure they can continue to deliver the same level of quality they’ve delivered in the past

Strategic partnerships among large companies have reshaped the research environment for industry players of every size.  Small and mid-sized companies who take the time to review current outsourcing arrangements, assess alternative models, and thoroughly qualify new vendors and partners will fare the best.

Photo Credit: FreeImages.com/Svilen Milev